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Distal Radial Fractures in the Late Middle Aged

NCT02353338 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2021-09-22

No results posted yet for this study

Summary

Background: Wrist fractures are a common injury among people aged 55-70. The radius is one of the bones making up the wrist joint, and is typically the site of injury in a broken wrist. Methods of treating a broken radius include placing the wrist in a cast for 6 weeks (conservative management) or receiving surgery. Surgery allows for earlier movement of the wrist and return to activity, while being placed in a cast is less invasive than surgery.

Surgery to fix these fractures has become more common; however there is little agreement about who should receive surgery and who should be placed in a cast to heal. The goal of this study is to compare outcomes between people aged 55-70 who have broken their wrist and had surgery, and those who received a cast.

Procedures: Participants in this study will be randomly assigned to one of two study groups within 1 week of injury at their first clinic visit with the surgeon.

Patients in Group A (surgical management) will continue with casting for a total of 6 weeks, as indicated by the surgeon.

Patients in Group B (conservative management) will receive surgery, and the attending surgeon will determine the best fracture fixation method for the wrist.

The research coordinator will assess the injured wrist at 6 weeks, 3, 6, and 12 months after the initial injury. At each assessment, the wrist will be examined and participants will be asked to fill in some questionnaires about health, pain, wrist function, and satisfaction with the wrist. An X-ray will also be performed on the wrist to assess bone healing. Information from each visit will be used to determine how participants are doing and to compare the 2 study groups.

Conditions

  • Radius Fracture

Interventions

PROCEDURE

Surgical intervention

Surgical management of radial fracture

PROCEDURE

Conservative management

Immobilized/cast for 6 weeks

DEVICE

cast

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-22
Primary Completion
2017-10-31
Completion
2018-09-21

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02353338 on ClinicalTrials.gov